CA2404641A1 - Oral delivery method and composition for solid medications or dietary supplements - Google Patents

Oral delivery method and composition for solid medications or dietary supplements Download PDF

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Publication number
CA2404641A1
CA2404641A1 CA002404641A CA2404641A CA2404641A1 CA 2404641 A1 CA2404641 A1 CA 2404641A1 CA 002404641 A CA002404641 A CA 002404641A CA 2404641 A CA2404641 A CA 2404641A CA 2404641 A1 CA2404641 A1 CA 2404641A1
Authority
CA
Canada
Prior art keywords
oral delivery
delivery composition
capsule
pill
tablet
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002404641A
Other languages
French (fr)
Other versions
CA2404641C (en
Inventor
Richard Fuisz
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Aquestive Therapeutics Inc
Original Assignee
Richard Fuisz
Monosol Rx Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Richard Fuisz, Monosol Rx Llc filed Critical Richard Fuisz
Publication of CA2404641A1 publication Critical patent/CA2404641A1/en
Application granted granted Critical
Publication of CA2404641C publication Critical patent/CA2404641C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4891Coated capsules; Multilayered drug free capsule shells

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

An oral delivery composition and method are provided for facilitating the swallowing of a solid object such as a pill, tablet, capsule or caplet. The oral delivery composition is made up of a mixture of a base liquid and at least one additive. The additive is selected and is present in the oral delivery composition in a sufficient concentration such that the oral delivery composition has improved physical properties, in comparison with the base liquid, so that when the oral delivery composition and a solid object to be swallowed by a user are administered together to the user and swallowed, the solid object is less likely to become lodged or stuck on tongue, throat, palate or oesophageal surfaces of the user, in comparison to when the base liquid and the solid object are administered together and swallowed.

Claims (23)

1. An oral delivery composition comprising:
a mixture of a base liquid and an additive or additives, wherein the additive or additives, individually or in combination, have the properties of a thickening agent, a surfactant and a lubricating agent and are selected and present in the oral delivery composition in a sufficient concentration such that the oral delivery composition has increased viscosity and wettability, in comparison with the base liquid, such that when the oral delivery composition and a solid object to be swallowed by a user are administered together to the user and swallowed, the solid object is less likely to become lodged or stuck on tongue, throat, palate or esophageal surfaces of the user, in comparison to when the base liquid and the solid object are administered together and swallowed, and wherein the oral delivery composition has a viscosity of between 10 and 20 centipoise at 36.5 °C.
2. A liquid oral delivery composition for facilitating the swallowing of a pill, caplet, capsule or tablet by a user, the oral delivery composition comprising:
a mixture of a base liquid and an additive or additives, wherein the additive or additives, alone or in combination, have the properties of a thickening agent, a surfactant and a lubricating agent and are selected and present in the oral delivery composition in a sufficient concentration such that the oral delivery composition has the following properties:
(1) a density that is greater than the density of the base liquid, (2) a surface tension that is less than the surface tension of the base liquid, (3) a viscosity that is greater than the viscosity of the base liquid, and is in the range of between 10 and 20 centipoise at 36.5 °C, (4) a wettability that is greater that the wettability of the base liquid, (5) a lubricity that is greater than the lubricity of the base liquid, and (6) a lower interfacial tension than the interfacial tension of the base liquid, such that when the oral delivery composition and the pill, caplet, capsule or tablet are administered together to a user and swallowed, the pill, caplet, capsule or tablet becomes wetted and engulfed by the liquid so that it is less likely to become lodged or stuck on tongue, throat, palate or esophageal surfaces of the user, in comparison to when the base liquid and the pill, caplet, tablet, or capsule are administered together and swallowed.
3. The oral delivery composition of Claim 2 wherein the base liquid comprises water.
4. The oral delivery composition of Claim 2 wherein the base, liquid comprises a fruit juice.
5. The oral delivery composition of Claim 2 wherein the additive or additives comprise a polysaccharide and a polysorbate surfactant.
6. The oral delivery composition of Claim 2 wherein the polysaccharide is selected from the group consisting of guar, locust bean, tamarind, arabic, karaya, tragacanth, agar, algin, carrageenan, xanthan, celluloses, pectins, carboxylated algin, carboxymethyl cellulose, hydroxypropylmethyl cellulose, carboxylated pectin, carboxylated xanthan, sulfated carrageenen, sulfated furcellaran and gellan.
7. The oral delivery composition of Claim 2 wherein the additive or additives comprise a water soluble cellulosic polymer and a polyoxyethylene sorbitan fatty acid ester.
8. The oral delivery composition of Claim 2 wherein the additive or additives comprise carboxyl methyl cellulose and polyoxyethylene sorbitan monooleate.
9. The oral delivery composition of Claim 2 wherein the oral delivery composition further contains at least one of sweeteners and flavors.
10. A composition comprising the oral delivery composition of Claim 1 and an undissolved pill, caplet, capsule or tablet.
11. A composition comprising the oral delivery composition of Claim 2 and an undissolved pill, caplet, capsule or tablet.
12. A composition comprising (a) a mixture of a base liquid, carboxyl methyl cellulose and polyoxyethylene sorbitan monooleate, wherein the mixture has a viscosity between 10 and 20 centipoise at 36.5 °C, and (b) an undissolved pill, caplet, capsule or tablet.
13. A method for swallowing a pill, caplet, capsule or tablet by a user, the method comprising the steps of:
providing an oral delivery composition comprising a mixture of a base liquid and an additive or additives, wherein the additive or additives, individually or in combination, have the properties of a thickening agent, a surfactant and a lubricating agent and are selected and present in the oral delivery composition in a sufficient concentration such that the oral delivery composition has a viscosity between 10 and 20 centipoise at 36.5 °C and increased wettability, in comparison with the base liquid such that when the oral delivery composition and a pill, caplet, capsule or tablet to be swallowed by a user are administered together to the user and swallowed, the pill, caplet, capsule or tablet is less likely to become lodged or stuck on tongue, throat, palate or esophageal surfaces of the user, in comparison to when the base liquid and the pill, caplet, capsule or tablet are administered together and swallowed, and administering the pill, caplet, capsule or tablet and the oral delivery composition together to a user.
14. A method for swallowing of a pill, caplet, capsule or tablet by a user, the method comprising the steps of:
providing an oral delivery composition comprising a mixture of a base liquid and an additive or additives, wherein the additive or additives, alone or in combination, have the properties of a thickening agent, a surfactant and a lubricating agent and are selected and present in the oral delivery composition in a sufficient concentration such that the oral delivery composition has the following properties:
(1) a density that is greater than the density of the base liquid, (2) a surface tension that is less than the surface tension of the base liquid, (3) a viscosity that is greater than the viscosity of the base liquid, and is in the range of between 10 and 20 centipoise at 36.5 °C, (4) a wettability that is greater that the wettability of the base liquid, (5) a lubricity that is greater than the lubricity of the base liquid, and (6) a lower interfacial tension than the interfacial tension of the base liquid, such that when the oral delivery composition and the pill, caplet, capsule or tablet are administered together to a user and swallowed, the pill, caplet, capsule or tablet becomes wetted and engulfed by the liquid so that it is less likely to become lodged or stuck on tongue, throat, palate or esophageal surfaces of the user, in comparison to when the base liquid and the pill, caplet, tablet, or capsule are administered together and swallowed, and administering the pill, caplet, capsule or tablet and the oral delivery composition together to the user.
15. The method of Claim 14 wherein the base liquid comprises water.
16. The method of Claim 14 wherein the base liquid comprises a fruit juice.
17. The method of Claim l4wherein the additive or additives comprise a polysaccharide and a polysorbate surfactant.
18. The method of Claim 17 wherein the polysaccharide is selected from the group consisting of guar, locust bean, tamarind, arabic, karaya, tragacanth, agar, algin, carrageenan, xanthan, celluloses, pectins, carboxylated algin, carboxymethyl cellulose, hydroxypropyl methyl cellulose, carboxylated pectin, carboxylated xanthan, sulfated carrageenen, sulfated furcellaran and gellan.
19. The method of Claim 14 wherein the additive or additives comprise a water soluble cellulosic polymer and a polyoxyethylene sorbitan fatty acid ester.
20. The method of Claim 14 wherein the additive or additives comprise carboxyl methyl cellulose and polyoxyethylene sorbitan monooleate.
21. The method of Claim 14 wherein the oral delivery composition further contains at least one of sweeteners and flavors.
22. The method of Claim 14 wherein the pill, capsule, caplet or tablet is elongated in one dimension and wherein, when the elongated pill, capsule, caplet or tablet is administered to a user together with the oral delivery composition, the oral delivery composition exerts a force on the elongated pill, capsule, caplet or tablet to cause the elongated pill, capsule or tablet to line up axially with the throat passage of the user.
23. The method of Claim 14 wherein the pill, capsule, caplet or tablet comprises a material that has a tendency to crumble or dissolve when exposed to water or natural fluids in the mouth of the user, and wherein, when the pill, capsule or tablet is administered to a user together with the oral delivery composition, the oral delivery composition facilitates the swallowing of the pill, capsule, caplet or tablet before crumbling or dissolving of the pill, capsule, caplet or tablet can occur in the mouth of the user.
CA2404641A 2000-04-05 2001-04-05 Oral delivery method and composition for solid medications or dietary supplements Expired - Fee Related CA2404641C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US19459200P 2000-04-05 2000-04-05
US60/194,592 2000-04-05
US09/672,949 2000-09-29
US09/672,949 US6337083B1 (en) 2000-04-05 2000-09-29 Oral delivery method and composition for solid medications or dietary supplements
PCT/US2001/010989 WO2001076634A1 (en) 2000-04-05 2001-04-05 Oral delivery method and composition for solid medications or dietary supplements

Publications (2)

Publication Number Publication Date
CA2404641A1 true CA2404641A1 (en) 2001-10-18
CA2404641C CA2404641C (en) 2010-10-26

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA2404641A Expired - Fee Related CA2404641C (en) 2000-04-05 2001-04-05 Oral delivery method and composition for solid medications or dietary supplements

Country Status (11)

Country Link
US (1) US6337083B1 (en)
EP (1) EP1385552B1 (en)
JP (1) JP2003530359A (en)
CN (1) CN1431916A (en)
AT (1) ATE364401T1 (en)
AU (2) AU2001249860B2 (en)
BR (1) BR0109917A (en)
CA (1) CA2404641C (en)
DE (1) DE60128966T2 (en)
MX (1) MXPA02009945A (en)
WO (1) WO2001076634A1 (en)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
USRE39125E1 (en) 2000-03-13 2006-06-13 Ryukakusan Co. Ltd Swallowing-assistive drink
EP1618149B1 (en) * 2003-04-25 2007-01-17 Reckitt Benckiser Healthcare (UK) Limited Thickenable compositions
US20050208108A1 (en) * 2004-03-19 2005-09-22 Jannusch Leonard C Thermoplastic films and methods for making
GB2430364A (en) * 2005-09-22 2007-03-28 Carl Ernest Alexander Soft agar bolus for oral drug delivery
US8187659B2 (en) * 2006-05-02 2012-05-29 Jerry Robertson Real Estate Llc Solid medicament dosage form consumption aid
US8383135B2 (en) 2010-12-03 2013-02-26 Richard C. Fuisz Solid dosage form that promotes reliable oral, esophageal and GI transit
US9452135B2 (en) 2012-03-20 2016-09-27 Particle Dynamics International, Llc Gelling agent-based dosage form
FR3001153B1 (en) 2013-01-21 2015-08-21 Eredova ASSISTING PRODUCT FOR THE INGESTION OF A SOLID COMPOUND
US11234897B2 (en) 2017-03-27 2022-02-01 DXM Pharmaceutical, Inc. Packaged multi-dose liquid dextromethorphan hydrobromide formulation
IT201800001301A1 (en) * 2018-01-18 2019-07-18 Univ Degli Studi Di Camerino Gel formulations for oral administration of drugs, particularly in dysphagia patients

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0610341B1 (en) * 1991-10-28 1996-09-18 The Procter & Gamble Company Beverage thickener/emulsifier system
JPH05139958A (en) * 1991-11-26 1993-06-08 Freunt Ind Co Ltd Easily swallowable agent
US5472711A (en) * 1992-07-30 1995-12-05 Edward Mendell Co., Inc. Agglomerated hydrophilic complexes with multi-phasic release characteristics
JPH0826976A (en) * 1994-07-21 1996-01-30 Freunt Ind Co Ltd Food-like medicine
JP4309481B2 (en) * 1996-01-12 2009-08-05 テイコクメディックス株式会社 Jelly oral pharmaceutical composition
US5643204A (en) * 1996-03-15 1997-07-01 Cover; Charles L. Pill swallowing device and method
US6709678B2 (en) * 1996-08-15 2004-03-23 Losan Pharma Gmbh Easy to swallow oral medicament composition
US6143276A (en) * 1997-03-21 2000-11-07 Imarx Pharmaceutical Corp. Methods for delivering bioactive agents to regions of elevated temperatures
JP3257983B2 (en) * 1997-07-31 2002-02-18 株式会社龍角散 Drug swallowing aid drink
JP3798913B2 (en) * 1998-07-31 2006-07-19 伊那食品工業株式会社 Additive for thickening
JP4248653B2 (en) * 1998-12-28 2009-04-02 ライオン株式会社 Easily swallowing assist composition, food composition and pharmaceutical composition using the same
WO2000044242A1 (en) * 1999-01-28 2000-08-03 Dainippon Pharmaceutical Co., Ltd. Intake/swallowing-assistant foods and process for producing the same

Also Published As

Publication number Publication date
JP2003530359A (en) 2003-10-14
ATE364401T1 (en) 2007-07-15
AU2001249860B2 (en) 2005-12-01
EP1385552A4 (en) 2005-08-10
AU4986001A (en) 2001-10-23
EP1385552A1 (en) 2004-02-04
CN1431916A (en) 2003-07-23
MXPA02009945A (en) 2004-08-19
BR0109917A (en) 2003-08-05
WO2001076634A1 (en) 2001-10-18
DE60128966T2 (en) 2008-02-28
DE60128966D1 (en) 2007-07-26
US6337083B1 (en) 2002-01-08
CA2404641C (en) 2010-10-26
EP1385552B1 (en) 2007-06-13

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Effective date: 20140407